FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/09/027652 [Registered on: 08/09/2020] Trial Registered Prospectively
Last Modified On: 31/08/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the effects of nasal packing with different strengths of adrenaline in nasal surgery on the nose and body  
Scientific Title of Study   Comparison of local and systemic effects of different concentrations of adrenaline nasal packs in endoscopic sinus surgery 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sunakshi Seigell 
Designation  Junior Resident 
Affiliation  GMCH 
Address  Department of ENT, head and neck surgery Government Medical Collage hospital sector 32 Chandigarh

Chandigarh
CHANDIGARH
160030
India 
Phone  9845351840  
Fax    
Email  sunakshiseigell12@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Surinder K Singhal 
Designation  Associate Professor 
Affiliation  GMCH 
Address  Department of ENT, head and neck surgery Government Medical Collage hospital sector 32 Chandigarh

Chandigarh
CHANDIGARH
160032
India 
Phone  9646121547  
Fax    
Email  singhalsks@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Surinder K Singhal 
Designation  Associate Professor 
Affiliation  GMCH 
Address  Department of ENT, head and neck surgery Government Medical Collage hospital sector 32 Chandigarh


CHANDIGARH
160032
India 
Phone  9646121547  
Fax    
Email  singhalsks@gmail.com  
 
Source of Monetary or Material Support  
Government Medical college and Hospital, Chandigarh 
 
Primary Sponsor  
Name  GMCH 
Address  Department ofENT head and neck surgery GMCH sector 32 Chandigarh 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Sunakshi Seigell  GMCH  Department of ENT head and neck surgery GMCH-32
Chandigarh
CHANDIGARH 
9845351840

sunakshiseigell12@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee GMCH Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J329||Chronic sinusitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  blood samples for testing  4 samples of venous blood will be drawn for assesment of level of adrenaline in plasma 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  All patients undergoing endonasal sinus surgery of age between 10-60 years and of either sex will be included in this study.  
 
ExclusionCriteria 
Details  Patients who have already undergone previous endoscopic sinus surgery.
Patients with uncontrolled hypertension, coronary artery disease or cerebro- vascular accident.
Patients who are younger than 10 years of age or older than 60 years of age
Patients operated under local anaesthesia.
Patients requiring infiltration of adrenaline.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Extent of adrenaline absorbed into systemic circulation after nasal packing with adrenaline soaked pledgets  measured at 0,4,8 and 15 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
the haemodynamic parameters of the patient, with different concentrations of adrenaline used.  at 0,4,8 and 15 minutes 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/09/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Endoscopic sinus surgery is the surgical procedure used in the management of chronic rhinosinusitis, benign nasal tumours as well as selected malignant nasal tumours as well as in diseases of the orbit. One of the challenges in endoscopic sinus surgery is proper visualization of anatomical landmarks and structures, due to the high vascularity of nose and paranasal sinuses. In addition to this, general anaesthesia causes an overall vasodilatory effect in the body, leading to a hyperaemic nasal mucosa. Adrenaline used either topically or by infiltration, to achieve hemostasis, has become popular as it is inexpensive and easily available in every hospital. Topical adrenaline in concentration of 1:1000, is the most commonly used vasoconstrictor for nasal packing currently. It aids in achieving haemostasis and prolonging the duration of action of local anaesthetics when added with them. By acting on both alpha and beta adrenergic receptors of the body, adrenaline produces effects like increased vasoconstriction (locally and systemically) and increased heart rate, cardiac output and contractility.These physiological effects of adrenaline pose a risk of complications like  hypertension, coronary ischemia, ventricular dysrhythmias and cerebral haemorrhage etc.

The literature regarding systemic absorption of adrenaline and comparing different concentrations of adrenaline and the effects it has on surgical visibility and hemodynamic parameters is very limited. Thus, this study is being done to assess the systemic absorption of adrenaline present in nasal packs, the haemodynamic effects caused by it and the improvement in surgical field obtained when two different concentrations of adrenaline are used.

 
Close